Sleep in Women With Bilateral Salpingo-Oophorectomy

Assessment of Sleep Disruption in Women With Bilateral Salpingo-Oophorectomy - A SCORE Ancillary Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04565158

Enrollment

Registered

2020-09-25

Start date

2020-12-14

Completion date

2023-11-06

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Salpingo-oophorectomy

Keywords

salpingo-oophorectomy, sleep, cognitive decline

Brief summary

The purpose of this research study is the compare objective and subjective sleep characteristics in women who have undergone removal of both ovaries (bilateral salpingo-oophorectomy) before natural menopause compared to women who did not undergo this procedure.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

55 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Women who participate in the parent SCORE studies (NCT03821857)

Exclusion criteria

* Night shift workers will be excluded

Design outcomes

Primary

Measure	Time frame	Description
prevalence of sleep disorders	2 years	prevalence of sleep disordered breathing, insomnia, and restless legs syndrome
prevalence of short sleep duration	2 years	objective sleep duration from actigraphy/polysomnography and subjective sleep duration from self-report
prevalence of poor sleep quality	2 years	objective sleep quality from actigraphy/polysomnography and subjective sleep quality from self-report

Other

Measure	Time frame	Description
exploratory correlation between sleep measures and cognitive function	2 years	correlation between objective and subjective sleep measures (sleep duration, sleep quality and sleep disorders) and tests of cognitive function (attention, memory, language, and global cognitive function)
exploratory correlation between sleep measures and neuroimaging	2 years	correlation between objective and subjective sleep measures (sleep duration, sleep quality and sleep disorders) and tests of cognitive function (attention, memory, language, and global cognitive function)

Countries

United States

Outcome results